Elderly patients with
dementia-related psychosis treated with antipsychotic drugs are at an increased
risk of death [see WARNINGS AND PRECAUTIONS]. SEROQUEL is not approved for the treatment of patients
with dementia-related psychosis [see WARNINGS AND PRECAUTIONS].

Suicidal Thoughts and
Behaviors

Antidepressants increased
the risk of suicidal thoughts and behavior in children, adolescents, and young
adults in short-term studies. These studies did not show an increase in the
risk of suicidal thoughts and behavior with antidepressant use in patients over
age 24; there was a reduction in risk with antidepressant use in patients aged
65 and older [see WARNINGS AND PRECAUTIONS]. In patients of all ages who are started on antidepressant therapy,
monitor closely for worsening, and for emergence of suicidal thoughts and
behaviors. Advise families and caregivers of the need for close observation and
communication with the prescriber [see WARNINGS AND PRECAUTIONS].

DRUG DESCRIPTION

SEROQUEL® (quetiapine fumarate) is a psychotropic agent
belonging to a chemical class, the dibenzothiazepine derivatives. The chemical
designation is 2-[2-(4-dibenzo [b,f]
[1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is
present in tablets as the fumarate salt. All doses and tablet strengths are
expressed as milligrams of base, not as fumarate salt. Its molecular formula is
C42H50N6O4S2•C4H4O4
and it has a molecular weight of 883.11 (fumarate salt). The structural formula
is:

Quetiapine fumarate is a white
to off-white crystalline powder which is moderately soluble in water.

What are the possible side effects of quetiapine (Seroquel, Seroquel XR)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Stop using quetiapine and call your doctor at once if you have a serious side...

What are the precautions when taking quetiapine fumarate (Seroquel)?

Before taking quetiapine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.